Optimisation of Primary HIV1 Infection Treatment(ANRS 147 OPTIPRIM)

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

ClinicalTrials.gov Identifier:

NCT01033760

First Posted: December 16, 2009

Last Update Posted: February 5, 2014

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Collaborators:

Gilead Sciences

Merck Sharp & Dohme Corp.

Pfizer

Janssen-Cilag Ltd.

Information provided by (Responsible Party):

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

The purpose of this trial is to assess the impact of raltegravir, maraviroc, darunavir/r, and Truvada® (emtricitabine/tenofovir) vs. darunavir/r and Truvada® on cell-associated HIV-DNA levels in patients with primary HIV-1 infection.

Primary HIV-1 infection is characterized by a phase of intense replication, with a quick dissemination and early changes in the immune system. During primary HIV-1 infection, damages to MALT and GALT promotes a chronic cell activation, which participates in a progressive decay of immune functions.

After HAART initiation, the magnitude and rapidity of cell-associated HIV-DNA decrease are significantly higher in patients with primary HIV-1 infection than in patients with chronic infection (Ngo Giang Huong, AIDS 2004).

We hypothesize that an early intervention at different levels of viral replication with potent and well-tolerated new drugs may have a greater impact on cell-associated HIV-DNA levels than conventional triple-drug HAART.

Eligibility

Information from the National Library of Medicine

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Primary infection: positive Elisa with incomplete Western-blot (≥ 2 and < 5 antibodies with the presence of anti-p24 antibodies associated with an anti-gp160 or an anti-gp120 or an anti-gp41antibody) and positive HIV-RNA.

Symptomatic Primary infection or CD4 <500/mm3

written informed consent

≥ 18 years old

Exclusion Criteria:

Prior post exposure antiretroviral treatment within six months before enrolment

Pregnancy or breast-feeding

HIV-2 infection

Current malignancy

Prothrombin time < 50%

Creatinine clearance < 60 ml/min

ASAT, ALAT or bilirubin ≥10*N

Platelets < 25000/mm3

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033760

Locations

France

Hôpital Gustave Dron

Tourcoing, France, 59208

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)